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NCT03229798 · ClinicalTrials.gov registry record · Phase 1
Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)
A Phase 1 study of Migraine Disorders, sponsored by Sorrento Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT03229798 is a Phase 1 study of Migraine Disorders that has completed, run by Sorrento Therapeutics. The registered enrollment target is 19 participants, below the 314-participant average among 21 other Migraine Disorders trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03229798, a Phase 1 study of Migraine Disorders, has completed, sponsored by Sorrento Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Study KCC-SMT-002, is a Phase 1, single-site, open-label, non-randomized, crossover, flexible dose design study to investigate the pharmacokinetic (PK) and safety comparing the Sofusa™ system with sumatriptan (KC5010) to Imitrex® oral tablets in 17 healthy volunteers.
Conditions Studied
Interventions
- DRUG Sumatriptan Succinate Oral Tablet
- COMBINATION_PRODUCT Transdermal delivery of sumatriptan succinate
Study Locations (1)
North Carolina
- Carolina Phase 1 Research - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-01-17 |
| Est. Completion | 2018-03-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03229798
The ClinicalTrials.gov registry entry for NCT03229798 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 314-participant average among 21 other Migraine Disorders trials with a reported enrollment target (94% lower). The listed sponsor is Sorrento Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Migraine Disorders appearing as the primary indexed condition, and to 2 interventions - of which Sumatriptan Succinate Oral Tablet is the first listed.
NCT03229798 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT03229798 about?
NCT03229798 is a clinical study titled "Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)". Study KCC-SMT-002, is a Phase 1, single-site, open-label, non-randomized, crossover, flexible dose design study to investigate the pharmacokinetic (PK) and safety comparing the Sofusa™ system with sumatriptan (KC5010) to Imitrex® oral tablets in 17 healthy volunteers.
What is the current status of trial NCT03229798?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2018-01-17. Estimated completion is 2018-03-28.
What conditions does trial NCT03229798 study?
This clinical trial studies the following conditions: Migraine Disorders.
What interventions are being tested in trial NCT03229798?
The interventions under investigation include: Sumatriptan Succinate Oral Tablet (DRUG), Transdermal delivery of sumatriptan succinate (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03229798?
This trial is sponsored by Sorrento Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03229798 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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